by Jason Clevenger, Ph.D., Jessica Vargas, Ph.D., Nicholas Benetatos, Ph.D., Megan Leonhard, M.P.H., and Diane Boesenberg
FTC scrutiny is expanding the scope of evidence-based claim substantiation, increasing the demands for valid scientific research
“Increase your metabolism.” “Clinically proven to reduce skin irritation.” “Supports joint health.”
Health-related claims can help sell a variety of consumer products. However, when claims may be misleading or lacking the appropriate level of scientific support, product manufacturers can face significant business and regulatory risks.
In an effort to ensure that health-related claims are “truthful, not misleading, and supported by science,” the Federal Trade Commission released its Health Products Compliance Guidance in 2022. This guidance, the first update from FTC since its 1998 Dietary Supplements: An Advertising Guide for Industry, expands the agency’s purview from dietary supplements to all health-related products, including foods, diagnostic tests, apps, medical devices, wearables, over-the-counter drugs, and more.
In addition to expanding its scope from dietary supplements to all health-related products, FTC’s guidance details how consumer product manufacturers need to substantiate their claims through “competent and reliable scientific evidence” and “clear and conspicuous disclosure.” The agency’s increased scrutiny signals that substantiation of new and existing health-related claims may need to be reviewed to confirm there is robust evidence the claims are truthful and not false or misleading based on updated guidelines.
Without substantiating their product health claims, manufacturers risk financial penalties and litigation, as well as the loss of time to market, money, and reputational damage that can come with having to retract or restate claims.
Regulation of consumer product health claims
Although this expansion in scope creates a situation where FTC and the Food and Drug Administration share jurisdiction over the marketing of devices, drugs, dietary supplements, foods, and other health-related products, they have different responsibilities. FTC has primary responsibility for regulating all advertising of foods, drugs, devices, and cosmetics but not their labeling. FDA has primary responsibility over the branding of foods, drugs, devices, and cosmetics, as well as the regulation of prescription drug advertising. FTC and FDA also have different legal frameworks — for instance, the FTC, unlike FDA, can’t exercise premarket approval over health-related claims.
Importantly, a product’s regulatory status can change depending on the claim. For example, dietary supplements making broad and far-reaching claims about being able to “diagnose, cure, treat, mitigate, or prevent” disease could be considered an unapproved drug under the Federal Food, Drug, and Cosmetic Act, subject to the requirements that apply to drugs, even if they are labeled as dietary supplements.
Trending toward increased substantiation
FTC has brought and adjudicated or settled more than 200 cases involving misleading or false health-related claims since 1998. Since 2021, FTC has brought or settled approximately 27 healthcare-related suits, including claims regarding deceptive marketing. Two key principles guide FTC’s actions:
1) Health-related claims must be truthful and not misleading (i.e., clear and conspicuous disclosure).
2) Before advertising health-related claims, advertisers must have adequate substantiation (i.e., robust, reproducible, competent and reliable scientific evidence) for all product claims conveyed expressly or implied, preferably based on peer-reviewed guidelines and published methodologies.
For example, a label on a vitamin bottle that claims 95% of orthopedists consume the product reflects an “expressly stated” claim (i.e., 95% of orthopedists take the product), as well as an “implied” claim because it suggests that the vitamin might support bone health since orthopedists take it. Both types of claims need substantiation.
In verifying these claims, stakeholders will want to think about how different audiences might interpret their health-related claims. Someone who has mobility issues for instance, may be more susceptible to an overstated claim like “boosts leg strength and mobility” than someone without mobility concerns. FTC also requires that qualifiers and disclosures must be “clear and conspicuous,” disclosing any limitations of a health-related claim. Rigorous substantiation can help reveal product claim limitations.
Factors affecting the required level of substantiation
According to the updated guidance, claims involving the safety and efficacy of health-related consumer products may receive a higher level of scrutiny and require increased substantiation. According to FTC, factors influencing the amount and type of substantiation required include:
- Product types: Consumer health and safety goods generally require a relatively high level of scientific substantiation.
- Claim types: Claims that are difficult for consumers to verify on their own — such as claims that cannot be verified without medical testing — may require more substantiation.
- Truthful claims that might benefit consumers but are difficult or expensive to verify: The costs and benefits of verifying claims may affect the level of substantiation required.
- Consequences of a claim being false: This could include both physical and economic injury, such as a consumer forgoing more effective treatment or the cost of buying an ineffective product.
- Expert opinion: What experts in the field consider a reasonable amount of substantiation can affect the level of substantiation required.
Steps for substantiating health-related claims
According to FTC, basic components of valid scientific research include a treatment and control (or comparison) group, randomization, and double blinding, as well as robust methodology and both statistically significant and clinically meaningful and, if necessary, actionable, results. Taking a scientific approach informed by the following steps can help product manufacturers obtain the evidence needed to understand the specific scope and parameters of their health-related claims and go to market with confidence:
1. Conduct a thorough critical review of the existing scientific literature and data on the product — including history of claims made and accepted — and relevant regulatory guidance and standards to identify gaps and opportunities in the evidence base, as well as potential risks and benefits of the claim.
2. Design a study to address a research question and hypothesis that will meet the regulatory expectations and criteria for the claim, including choosing the appropriate study design, such as a randomized controlled trial or an observational study; selecting the relevant outcome measures, such as biomarkers, clinical endpoints, or subjective ratings; defining the study population, sample size, and inclusion and exclusion criteria; and determining the study duration.
3. Create a statistical analysis plan and perform data analysis that can answer the research question and hypothesis and evaluate the statistical significance and clinical relevance of the results — which may include applying appropriate statistical analyses to test the assumptions and limitations of the data and the methods — and reporting the findings.
4. Synthesize and communicate the evidence in a clear and concise manner that can support evaluation of the claim, which may include preparing a complete study report, manuscript, or presentation that summarizes the study objectives, methods, results, and conclusions; highlighting the strengths and weaknesses of the evidence; providing recommendations regarding whether the claim is supported; and outlining the implications of the claim.
Looking to the future of advertising
Although FTC’s guidance update was its first in many years, consumer product companies can benefit from thinking about how the stakes for substantiation could increase going forward. In the context of evolving advertising platforms like augmented reality (AR) labels, product claims may be presented to consumers in new ways (e.g., multiple languages, additional content unable to fit on a standard label) with the potential to increase consumer engagement and improve consumer interactions and label understanding — quickly delivering more information than a two-dimensional label can provide. With the touch of a button, consumers may be able to scan AR labels with smart phone cameras to receive a variety of content, including videos, customized messaging, related product recommendations, social media, and much more. With these advances, companies should also be mindful of equitable access for populations or communities who may not have access to AR or smart phones and will continue to rely on traditional labels.
While these labels and others like them may offer added value for consumer products companies — fostering brand loyalty and influencing purchasing decisions with increased speed to different demographics — it’s more than likely that as messaging related to health-related digital claims becomes more prominent, so will the demand from regulatory entities in substantiating them. To capitalize on early and ongoing opportunities on these platforms and others, well-designed scientific studies have the potential to help companies appropriately scope and collect the evidence that might be needed for future health-related claims, helping them take advantage of fast-evolving market and advertising trends.
